Software Design Engineer Visa Sponsorship Jobs in Massachusetts
Software design engineer visa sponsorship jobs in Massachusetts are concentrated in Greater Boston, where employers like Apple, Amazon, Microsoft, and a dense cluster of biotech and fintech firms actively hire and sponsor international talent. Cambridge, Boston, and Waltham are the primary hiring hubs, supported by a strong pipeline from MIT, Harvard, and Northeastern.
Find Software Design Engineer JobsOverview
Showing 5 of 739+ Software Design Engineer Jobs in Massachusetts with Visa Sponsorship
See all 739+ Software Design Engineer Jobs in Massachusetts with Visa Sponsorship
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Software Design Engineer Jobs in Massachusetts with Visa Sponsorship.
Get Access To All JobsINTRODUCTION
The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices.
KNOWLEDGE
- In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems.
- Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems.
- Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA.
- Familiarity with usability principles and IEC 62366 to enhance product safety and effectiveness.
- Knowledge of regulatory and safety challenges for AI/ML in medical devices.
- Proficiency in statistical software (e.g., Minitab) for data analysis.
SKILLS
- Ability to mature Quality Management System (QMS) processes using Agile/iterative design controls.
- Hands-on experience in full SDLC for safety-critical applications.
- Defining and executing robust software verification and validation (V&V) strategies.
- Integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
- Advanced project documentation, requirements management, and version control.
- Software security skills, including threat modeling, vulnerability assessments, and penetration testing.
- Excellent communication for cross-functional collaboration and technical presentations.
BEHAVIOR
- Collaborative approach, working closely with cross-functional teams (R&D, Regulatory, Marketing, Manufacturing Engineering, Quality Engineering).
- Leadership in guiding teams on best practices for software development and compliance.
- Proactive in identifying process gaps, recommending improvements, and supporting continuous improvement initiatives.
- Creative and effective problem-solving, ensuring innovative solutions without compromising quality or compliance.
- Commitment to maintaining compliance with all regulatory requirements and internal policies.
Experience
- Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline with 5+ years of medical device industry experience, or a Master’s degree with 3+ years of experience.
- Proven track record in applying medical device regulations and standards to software projects.
- Experience in leading design assurance activities, risk management, verification, and validation throughout the product lifecycle.
- Participation in new product development and sustaining product projects, ensuring clear scope and objectives are met.
- Involvement in regulatory inspections and remediation initiatives.
WHY JOIN Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
AGENCY AND THIRD-PARTY RECRUITER NOTICE
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
INTRODUCTION
The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices.
KNOWLEDGE
- In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems.
- Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems.
- Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA.
- Familiarity with usability principles and IEC 62366 to enhance product safety and effectiveness.
- Knowledge of regulatory and safety challenges for AI/ML in medical devices.
- Proficiency in statistical software (e.g., Minitab) for data analysis.
SKILLS
- Ability to mature Quality Management System (QMS) processes using Agile/iterative design controls.
- Hands-on experience in full SDLC for safety-critical applications.
- Defining and executing robust software verification and validation (V&V) strategies.
- Integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement.
- Advanced project documentation, requirements management, and version control.
- Software security skills, including threat modeling, vulnerability assessments, and penetration testing.
- Excellent communication for cross-functional collaboration and technical presentations.
BEHAVIOR
- Collaborative approach, working closely with cross-functional teams (R&D, Regulatory, Marketing, Manufacturing Engineering, Quality Engineering).
- Leadership in guiding teams on best practices for software development and compliance.
- Proactive in identifying process gaps, recommending improvements, and supporting continuous improvement initiatives.
- Creative and effective problem-solving, ensuring innovative solutions without compromising quality or compliance.
- Commitment to maintaining compliance with all regulatory requirements and internal policies.
Experience
- Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline with 5+ years of medical device industry experience, or a Master’s degree with 3+ years of experience.
- Proven track record in applying medical device regulations and standards to software projects.
- Experience in leading design assurance activities, risk management, verification, and validation throughout the product lifecycle.
- Participation in new product development and sustaining product projects, ensuring clear scope and objectives are met.
- Involvement in regulatory inspections and remediation initiatives.
WHY JOIN Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
AGENCY AND THIRD-PARTY RECRUITER NOTICE
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Software Design Engineer Job Roles in Massachusetts
See all 739+ Software Design Engineer Jobs in Massachusetts
Sign up for free to filter by visa type, set job alerts, and find employers with verified sponsorship history.
Search Software Design Engineer Jobs in MassachusettsSoftware Design Engineer Jobs in Massachusetts: Frequently Asked Questions
Which companies sponsor visas for software design engineers in Massachusetts?
Large technology employers with significant Massachusetts offices, including Apple, Amazon, Microsoft, Google, IBM, and HubSpot, have consistent histories of sponsoring H-1B visas for software design engineers. Boston's biotech and life sciences sector, with companies like Biogen, Moderna, and Vertex Pharmaceuticals, also sponsors software design engineering roles that support their research and product platforms.
Which visa types are most common for software design engineer roles in Massachusetts?
The H-1B is the most common visa for software design engineers in Massachusetts, as the role typically qualifies as a specialty occupation requiring at least a bachelor's degree in computer science, software engineering, or a related field. Candidates already in the U.S. on OPT or STEM OPT, particularly graduates of Massachusetts universities, frequently transition into H-1B sponsorship with Boston-area employers.
Which cities in Massachusetts have the most software design engineer sponsorship jobs?
Boston and Cambridge account for the largest share of software design engineer sponsorship activity in Massachusetts, driven by the concentration of technology companies, startups, and academic institutions in those cities. Waltham, Burlington, and Woburn are also significant hiring corridors along Route 128, historically known as Massachusetts' technology belt, where many established tech and defense-adjacent firms operate engineering teams.
How to find software design engineer visa sponsorship jobs in Massachusetts?
Migrate Mate filters job listings specifically by visa sponsorship availability, making it straightforward to search for software design engineer roles in Massachusetts without sorting through positions that don't offer sponsorship. You can narrow results by location, employer type, and role to focus on Massachusetts-based opportunities at companies with documented sponsorship histories in software design engineering.
Are there state-specific considerations for software design engineers seeking sponsorship in Massachusetts?
Massachusetts employers sponsoring H-1B workers must pay the prevailing wage for the specific role and location, which in the Greater Boston metro tends to reflect a high-cost labor market. The density of research universities in Massachusetts, including MIT, Northeastern, and Boston University, creates a strong local OPT talent pipeline, meaning many employers in the state have established sponsorship processes already in place for engineering roles.
What is the prevailing wage for sponsored software design engineer jobs in Massachusetts?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.